Abstral is a medicine used to manage breakthrough cancer pain in people who are already taking other narcotic painkillers around-the-clock for their cancer pain. Abstral is started only after you have been taking other narcotic painkillers and your body has become used to them (you are "opioid-tolerant"). Abstral is available as a sublingual tablet (a tablet that is dissolved under your tongue).

Abstral is a federally controlled substance because it has abuse potential.

What should I know when beginning and continuing on this medication?

How does this medication work?

Abstral works in your central nervous system (the brain and spinal cord) and affects the way your body responds to pain.

What are the beneficial effects of this medication and when should I begin to have results?

What: Abstral has been shown to help relieve pain.

When: You may begin to feel a relief in your pain within 30 minutes. It is important that you use Abstral exactly as your healthcare provider has prescribed.

How do I know it is working?

You may feel an improvement in your pain. This is a good indicator that the medicine is working. Your healthcare provider may also ask you questions from time to time to assess how well your symptoms are controlled with treatment.

What are the possible side effects of this medication?

The following is not a full list of side effects. Side effects cannot be anticipated. If any develop or change in intensity, tell your healthcare provider as soon as possible. Only your healthcare provider can determine if it is safe for you to continue taking this medication.

Due to the risk of serious, life-threatening breathing problems, do not use Abstral unless you are regularly using another narcotic painkiller around-the-clock for at least one week or longer for your cancer pain and your body is used to these medicines. Also, do not use Abstral to treat pain that you only have now and then ("as needed"), or after surgery if the pain is mild or not expected to last for a long period (including headaches/migraines). Tell your healthcare provider right away if you are breathing more slowly than usual; are experiencing shallow breathing (little chest movement while breathing); or if you feel faint, dizzy, confused, or have any other unusual symptoms.

Keep Abstral in a safe place away from children. Accidental use may result in serious harm and may be life-threatening.

Abstral has abuse potential. If you have concerns, talk to your healthcare provider for more information about abuse and addiction. Do not share Abstral with others and take steps to protect Abstral from theft or misuse.

Abstral is available only through a program called the Transmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) Access Program. Under this program, you must talk to your healthcare provider, understand the benefits and risks of Abstral, agree to all the instructions, and sign the Patient-Prescriber Agreement form in order to receive Abstral.

More common side effects may include: nausea, sleepiness, headache, constipation.

Less common side effects may include:

Abstral may lower your heart rate.

Who should not take this medication?

Do not take Abstral if you are allergic to it or any of its ingredients.

Do not take Abstral if you are not opioid-tolerant.

Do not take Abstral to treat pain that you only have now and then ("as needed"), or after surgery if the pain is mild or not expected to last for a long period (such as headaches, migraines, or dental pain).

What should I tell my healthcare provider before I take the first dose of this medication?

Tell your healthcare provider about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Abstral. Also, talk to your healthcare provider about your complete medical history, especially if you have a head injury or brain problems; trouble breathing or lung problems (such as asthma, wheezing, or shortness of breath); liver or kidney problems; seizures; a slow heart rate or other heart problems; low blood pressure; mental health problems (such as major depression, schizophrenia, or hallucinations); a history of drug or alcohol addiction or a family history of these problems; or if you are pregnant, plan to become pregnant, or are breastfeeding.

What is the usual dosage?

The information below is based on the dosage guidelines your healthcare provider uses. Depending on your condition and medical history, your healthcare provider may prescribe a different regimen. Do not change the dosage or stop taking your medication without your healthcare provider's approval.

Take Abstral exactly as prescribed by your healthcare provider. Do not change your dose without first talking to your healthcare provider.

Place the Abstral tablet under your tongue. Do not suck, chew, or swallow the tablet.

Take one dose of Abstral for an episode of breakthrough cancer pain. If your pain is not relieved within 30 minutes after taking the first dose, take only one more dose at this time. If your pain does not get better after the second dose, call your healthcare provider for instructions. Do not take another dose at this time.

Wait at least 2 hours before treating a new episode of breakthrough cancer pain with Abstral. Talk to your healthcare provider if you have more than 4 episodes of breakthrough cancer pain per day. The dose of your around-the-clock pain medicine may need to be adjusted.

Please review the instructions that came with your prescription on how to take Abstral properly.

When you stop taking Abstral, remove any remaining tablets from the blister package, and flush them down the toilet.

What should I avoid while taking this medication?

Do not drive a car, operate machinery, or engage in other dangerous activities until you know how Abstral affects you.

Do not drink alcohol or take prescription or over-the-counter medicines that contain alcohol while you are taking Abstral.

What are the possible food and drug interactions associated with this medication?

If Abstral is taken with certain other drugs, the effects of either could be increased, decreased, or altered. Abstral may interact with numerous medications. Therefore, it is very important that you tell your healthcare provider about any other medications you are taking.

May I receive this medication if I am pregnant or breastfeeding?

The effects of Abstral during pregnancy are unknown. Abstral can be found in your breast milk if you take it while breastfeeding. Do not take Abstral while you are breastfeeding. Tell your healthcare provider immediately if you are pregnant, plan to become pregnant, or are breastfeeding.

What should I do if I miss a dose of this medication?

Abstral should be used under special circumstances determined by your healthcare provider. If you miss your scheduled dose, contact your healthcare provider or pharmacist for advice.

How should I store this medication?

Store at room temperature. Protect from moisture.

Who should I contact in case of emergency or overdose?

In the event of a medical emergency call your doctor or 9-1-1 immediately. In the event of overdose, call your doctor or poison control for further instructions.
National Poison Control#: Call 1-800-222-1222

This PDR+ drug information has been developed by the Physicians’ Desk Reference Network (PDRN), a source of medication information trusted by doctors for over 65 years.

This monograph summarizes the most important information about your
medication and does not cover all the information you may need. If you
have any questions or concerns or want to learn more about your
medication, ask your healthcare provider; he/she will be able to provide
answers to your questions. This medication should only be used by the
patient for whom it was prescribed and should not be shared with other
people.

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